Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-27 @ 5:13 PM
Study NCT ID:
NCT07225192
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-21
First Post:
2025-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therapy and Tech Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098647', 'term': 'Generalized Anxiety Disorder'}, {'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 204}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-11-03', 'studyFirstSubmitQcDate': '2025-11-03', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Generalized Anxiety Disorder (GAD-7)', 'timeFrame': 'Baseline, 4-week follow-up, 8-week follow-up', 'description': 'Questions about symptoms of generalized anxiety disorder. Scale is 0-21. Higher scores is a worse outcome.'}, {'measure': 'Patient Health Questionnaire (PHQ-9)', 'timeFrame': 'Baseline, 4-week follow-up, 8-week follow-up', 'description': 'Questions about symptoms of depression. Scale is 0-27. Higher score is a worse outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Generalized Anxiety Disorder (GAD)', 'Major Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'The investigators want to test if gen AI can support therapy by recruiting patients already in therapy.', 'detailedDescription': "Recent advancements in AI have led to chatbots, such as ChatGPT, capable of providing therapeutic responses. Early research evaluating chatbots' ability to provide relationship advice and single-session relationship interventions has showed that both laypeople and relationship therapists rate them high on attributes such as empathy and helpfulness. The investigators want to test if chatbots can be a good adjunct to traditional therapy. The investigators hypothesize that participants who regularly use a chatbot as an adjunct to traditional therapy will have better mental health outcomes. Participants will complete baseline, 4-week (post-intervention) and 4-week post-intervention measures and will be invited to gain their therapists ratings."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18+\n* US Resident\n* English-speaking\n* Self-report having been treated for or diagnosed with generalized anxiety disorder or major depressive disorder by a licensed provider (e.g., MD, DO, LPCC, LCSW, LMFT) in the past 12 months\n* Self-report currently being in individual therapy\n\nExclusion Criteria:\n\n* Ever diagnosed with schizophrenia, schizoaffective disorder, bipolar disorder, or hospitalized for suicidality'}, 'identificationModule': {'nctId': 'NCT07225192', 'briefTitle': 'Therapy and Tech Study', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Irvine'}, 'officialTitle': 'Therapy and Tech Study', 'orgStudyIdInfo': {'id': 'STUDY00000488'}, 'secondaryIdInfos': [{'id': '4R33AT010606', 'link': 'https://reporter.nih.gov/quickSearch/4R33AT010606', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chatbot Therapy Group', 'description': 'Group 1 will be asked to use an AI chatbot like chatgpt as an adjunct to their regular therapy', 'interventionNames': ['Behavioral: Chatbot Therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Group 2 will be asked to continue their regular therapy as usual.'}], 'interventions': [{'name': 'Chatbot Therapy', 'type': 'BEHAVIORAL', 'description': 'This group will be asked to use an AI chatbot like chatgpt as an adjunct to their regular therapy', 'armGroupLabels': ['Chatbot Therapy Group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Irvine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Emergency Medicine and Informatics', 'investigatorFullName': 'Sean D Young', 'investigatorAffiliation': 'University of California, Irvine'}}}}